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Completed

NCT Number: NCT04886817

Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families

Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27028, United States

About this study

This is a pilot 2-arm randomized trial among 60 families of 1-8 year old children who currently over-consume sugary drinks. The study team will randomize families to either an intervention group, that will receive a behavioral intervention consisting of an educational video, water promotion toolkit, mobile phone app, and series of educational phone calls, or to a control group that will not receive this intervention. The study team will compare 6-month change in child and parental beverage consumption between groups. Exploratory analyses will examine child weight (kg) and Body Mass Index (BMI) z-score (BMIz) outcomes, and compare intervention effects across race/ethnic groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child 1-8 years old who receives health care attention at Wake Forest pediatric or family medicine practices
  • Child consumes 2 or more SSB and/or fruit juice total per day
  • Child with no chronic health condition
  • Child has not seen nutritionist or visited our family-based weight management clinic in the past year
  • parent/caregiver who has not watch educational video "Get in the Zero Zone"
  • parent/caregiver has a smartphone and reliable internet
  • parent/caregiver able to communicate well in English

Exclusion criteria

  • Child doesn't meet age criteria
  • Child consumes less than 2 SSB and/or fruit juice total per day
  • Child with a chronic health condition
  • Child has seen nutritionist or visited our family-based weight management clinic in the past year
  • parent/caregiver has watched educational video "Get in the Zero Zone"
  • parent/caregiver has completed interview or usability test
  • parent/caregiver doesn't have a smartphone or reliable internet
  • parent/caregiver not able to communicate well in English

Treatment and study plan

Pilot Intervention to reduce SSB consumption in children and families

Behavioral

A 6-month intervention based on the use of 4 components: an educational video, provision of a water-promotion "toolkit," a mobile phone application (app), and a series of 14 computerized interactive voice response (IVR) phone calls to parents to compare families' SSB's consumption behaviors

Primary outcomes

  1. Change in child sugary drink serving consumption

    Time frame: from baseline to month 3

    change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 3 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument

  2. Change in child sugary drink serving consumption

    Time frame: from baseline to month 6

    change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument

Secondary outcomes

  1. BevQ 15 - Children Change in Servings of Beverages

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total servings children including water and unsweetened milk

  2. BevQ 15 - Children Change in total Volume of Beverages

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume of beverages consumed by children including water and unsweetened milk

  3. BevQ 15 - Children Change in total calories of beverages consumption

    Time frame: from baseline to month 3, from baseline to month 6

    Changes in calories of beverages consumed by children including water and unsweetened milk

  4. BevQ 15 -Parental Change in Sugary beverage consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in parental beverage consumption sugary drink serving

  5. BevQ 15 -Parental Change in Beverage Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total servings for parents including water and unsweetened milk

  6. BevQ 15 -Parental Change in Volume of Beverage Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume for parents including water and unsweetened milk

  7. BevQ 15-Parental Change in Calories of Beverage Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total beverage calories for parents including water and unsweetened milk

  8. Changes in parent knowledge

    Time frame: from baseline to month 3, from baseline to month 6

    Survey knowledge items will be "scored" in terms of correct or not with a range of 0-17 possible points, with higher score demonstrating more knowledge about SSB and FJ, including how SSB are related to possible health consequences and perceived healthfulness of different beverages.

  9. Changes in Parent Attitudes

    Time frame: from baseline to month 3, from baseline to month 6

    Attitude and belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data.

  10. Changes in Parent Beliefs

    Time frame: from baseline to month 3, from baseline to month 6

    Belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data.

  11. Child Weight Change

    Time frame: from baseline to month 3, from baseline to month 6

    change in child weight (kg) using Electronic Health Record (EHR) data

  12. Child Body Mass Index Z-Score (BMIz) Change

    Time frame: from baseline to month 3, from baseline to month 6

    change in child BMIz also using EHR data

Other outcomes

  1. Single Item Literacy Screener (SILS)

    Time frame: baseline

    The SILS is a single item question intended to identify adults in need of help with printed health material. The SILS asks, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" Possible responses are 1-Never, 2-Rarely, 3-Sometimes, 4-Often, and 5-Always

  2. Modified Version of the Mobile Device Proficiency Questionnaire (MDPQ)

    Time frame: baseline

    This questionnaire asks about the ability to perform a number of tasks with a mobile device. The MDPQ asks seniors to select how easily they could perform 19 mobile device skills from Not at all, Not very easily, Somewhat easily, or very easily.

  3. NCI's 26-item Dietary Screener Questionnaire (DSQ)

    Time frame: baseline, month 6

    The study team will use only 19 items of the DSQ to assess intake of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium. DSQ will be asked of parent, responding for child and will exclude questions about beverages as those would be redundant to questions already included in the Bevq-15 instrument.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Health Systems Intervention to Reduce Sugar-Sweetened Beverage Consumption in Young Children and Families

Acronym: SCOPE-IT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 14, 2021
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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